医学总监，胃肠道与炎症
Medical Director, Gastrointestinal & Inflammation
通过点击“申请”按钮，我理解我的辉瑞就业申请流程将开始，并且我提供的申请信息将按照辉瑞的隐私通知和使用条款进行处理。我进一步确认，我提交的所有就业申请信息均基于我的知识，是真实准确的。
职位描述
您是否正在寻找一家以患者为中心、创新驱动的公司，它将激励您并赋予您发光发热的力量？加入我们，在马萨诸塞州剑桥市办公室担任胃肠病学与炎症医学总监。
在辉瑞，我们通过以研发为导向的市场领导地位，正在改变制药行业，并作为一家以价值观为导向的公司。为此，我们赋能员工，通过具有变革意义的工作实现他们的潜力。我们被认证为全球顶级雇主，提供充满挑战的职业，鼓励创新，并在我们所做的每件事中追求卓越。我们营造一个包容、协作的工作环境，我们的全球团队因致力于为世界各地的人们带来更好的健康和更光明的未来而团结一致。
在这里，您将成为我们鼓舞人心、大胆使命的重要贡献者。
职位目标：
主要职责包括：
- 作为全球安全负责人（GSL）和公司范围内的患者安全专家，负责指定的药品/生物制品/药物设备组合产品的安全策略和主要安全交付成果。
- 领导指定化合物和产品的GPSE安全团队（GST）和安全管理体系（SMT）。
- 作为产品安全概况和风险缓解专家，代表跨职能项目团队，向内部（如辉瑞安全委员会）和外部（如独立数据监测委员会）利益相关者进行沟通。
- 管理对指定化合物和产品的获益-风险概况的跨职能评估，并传达安全信息。
职位职责：
- 分析和解释来自各种来源的安全数据，包括非临床、临床、上市后和科学文献。
- 对指定的化合物和产品进行信号检测、监控、评估、解释和管理。
- 制定策略并领导对监管机构和伦理委员会的安全相关查询的回应准备。
- 确保所有可能影响指定产品获益-风险概况的安全信息传达给高级管理层。
查看英文原文
By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.
Job Description
Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Medical Director, Gastrointestinal & Inflammation in our Cambridge, MA office.
At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
Here, you will be a vital contributor to our inspiring, bold mission.
POSITION OBJECTIVES:
Principal responsibilities include:
- Serves as Global Safety Lead (GSL) and the Company-wide patient safety expert for assigned pharmaceutical / biological / drug-device combined products, accountable for the safety strategy and major safety deliverables for each assigned product.
- Leads GPSE Safety Team (GST) and Safety Management Team (SMT) for assigned compounds and products.
- Represents the cross-functional program team as a product safety profile and risk mitigation expert for internal (e.g., Takeda Safety Board) and external (e.g., Independent Data Monitoring Committee) stakeholders.
- Manages cross-functional assessment of benefit-risk profile and communication of safety information for assigned compounds and products.
POSITION ACCOUNTABILITIES:
- Analyze and interpret safety data from various sources including non-clinical, clinical, post-marketing and scientific literature.
- Conduct signal detection, monitoring, evaluation, interpretation, and management for assigned compounds and products.
- Develop strategy for and lead preparation of responses to safety-related inquiries from regulatory agencies and ethics committees.
- Ensure communication of all safety information that may impact the benefit-risk profile of assigned products to senior management.
- Provide medical safety expertise, medical interpretation, review, and authorship of appropriate sections for critical documents (e.g., protocols and amendments, ICFs, IBs, IMPDs, clinical research reports, Health Hazard Evaluations, Signal Evaluation Reports, INDs, NDAs, BLAs, and CTAs) in collaboration with cross-functional colleagues.
- Provide patient safety input to the clinical development program for assigned products and development compounds, and represent GPSE on internal governance bodies for study protocols, statistical analysis plans and other clinical study-related documents as applicable.
- Manage benefit-risk profile, including authoring and updating of the benefit-risk documents, e.g., RMPs, for assigned compounds and products.
- Collaborate and communicate safety issues with other functional areas such as Clinical Development, Regulatory Affairs, Quality Assurance, Medical Affairs, Marketing, Manufacturing, and Legal.
- Interact with Regulatory Authorities as part of a cross-functional team to submit and defend regulatory inquires, MAAs, NDAs, and BLAs.
- Ensure up-to-date representation of safety information in Company Core Data Sheet (including Reference Safety Information) and Investigator Brochure, as well as other labeling documents.
- Demonstrate knowledge of local and global health authority requirements.
- Support GPSE in the maintenance of a highly effective global safety organization in full compliance to worldwide regulations.
- Train and mentor Pharmacovigilance Physicians and Specialists.
- Maintain professional knowledge and accreditation by active participation in continuing medical education activities, and fosters a community of continual learning.
EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:
- M.D. or D.O. or internationally recognized equivalent, with direct clinical experience in patient care following post-graduate training and appropriate grounding and knowledge of general medicine. Board certification and licensure preferred.
- At least 5 years of experience in pharmaceutical industry within Drug Safety/Pharmacovigilance, with both investigational and marketed products.
- At least 3 years of experience with aggregate reporting, safety surveillance, signal management and/or risk management.
- Knowledge and understanding of national and international PV and regulatory guidelines.
Travel Requirements:
· Local and international travel across Takeda sites may be required.
This position is currently classified as “ remote” in accordance with Takeda’s Hybrid and Remote Work policy.
Empowering Our People to Shine
Discover more at takedajobs.com
No Phone Calls or Recruiters Please.
Locations
Massachusetts - VirtualWorker Type
EmployeeWorker Sub-Type
RegularTime Type
Full timeOriginally posted on Himalayas